Can a new drug make anesthesia safer and more effective?
NCT ID NCT07733245
First seen Jul 29, 2026 · Last updated Sep 10, 2026 · Updated 3 times
Summary
This trial tests an experimental drug called HRS-9190 to see if it can relax muscles enough for placing a breathing tube and keep them relaxed during surgery. It compares HRS-9190 to a standard muscle relaxant, rocuronium, in adults having planned surgery under general anesthesia. The goal is to find out if HRS-9190 works as well or better, and how safe it is.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- an experimental muscle relaxant called HRS-9190
- What this could lead to
- If effective, HRS-9190 could offer a new option for muscle relaxation during general anesthesia, potentially with a different safety profile.
- What could go wrong
- This is a phase 3 trial, but HRS-9190 is still experimental. It may not prove superior or safer than existing drugs, and side effects are possible.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 320 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Sep 2026
- Expected to finish
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Mar 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 75 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Voluntarily sign ICF before starting trial-related activities, fully understand the purpose and significance of this trial, and voluntarily abide by the process of this trial; 2. For elective surgery, tracheal intubation should be performed under general anesthesia and intermittent drug administration is suitable for intraoperative muscle relaxation maintenance, and the operation time is expected to be 1.5-4 hours; 3.18 years old ≤ age ≤75 years old, regardless of gender; 4\. 18.0 kg/m2≤ body mass index (BMI) ≤28.0 kg/m2; 5. ASA grade I-II; 6. Female participants of childbearing potential must agree to use highly effective contraception with their partner and avoid egg donation from the time they sign the ICF until 1 month after the last dose of the investigational drug, have a negative serum pregnancy test during the screening period, and are not lactating; Men whose partner was a woman of childbearing potential agreed to use highly effective contraception with their partner and to avoid sperm donation from the time they signed the ICF until 1 month after the last dose of the investigational product. Exclusion Criteria: 1. previous neuromuscular diseases: myasthenia gravis, myasthenic syndromes, myotonic disorders, poliomyelitis, etc. Previous immune diseases requiring long-term steroid therapy (3 months or more); 2. a history of myocardial infarction or unstable angina, a history of severe arrhythmia such as atrioventricular block degree II or higher, or a history of New York Heart Association (NYHA) functional class II or higher within 6 months before screening that was deemed by the investigator to increase the risk of sedation/anesthesia; Participants with hypertension or hypotension who had poorly controlled blood pressure (systolic blood pressure ≥160 mmHg or ≤90 mmHg at screening; and/or diastolic blood pressure ≥100 mmHg or ≤60 mmHg at screening); Previous history of ischemic stroke or transient ischemic attack (TIA); Participants with psychiatric disorders (e.g., schizophrenia, depression, etc.) and cognitive impairment, or a history of epilepsy, or previous history of psychotropic or narcotic drug abuse; 3. The presence of severe respiratory diseases such as chronic obstructive pulmonary disease or bronchial asthma; Or those with obstructive sleep apnea syndrome, as assessed by investigators, who might be at risk for difficult intubation; 4. abnormal body temperature \>37.5℃ or \<36℃ during the screening period; He had a history of malignant high fever. Hypothermia surgery was planned. 5. having a history of drug, drug, or alcohol abuse within 1 year before randomization 6. QTc (QTcF= QT/RR0.33) : male \>450 ms, female \>470 ms; 7. Abnormal liver function during screening: aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) ≥1.5 times upper limit of normal (ULN) and/or total bilirubin (TBIL) ≥1.5 times ULN; Abnormal renal function during screening: serum creatinine (Cr) ≥1.5 times upper limit of normal (ULN); Serum albumin (ALB) during screening was less than 35g/L; 8. electrolyte disturbance or known dehydration, acid/alkalosis, hypercapnia, or other factors assessed by the investigator during the screening period; 9. positive for human immunodeficiency virus (HIV) antibody, syphilis antibody, hepatitis B surface antigen, and hepatitis C virus (HCV) antibody; 10. previous allergy to neuromuscular blocking drugs or other drugs that may be used during the trial; 11. use other drugs that affect the effect of muscle relaxant, and the interval between the last use and the random time is less than 5 half-lives (according to the actual drug instructions, the half-life is unknown, then the elution is according to 48 hours) : Neuromuscular blockers, cholinesterase inhibitors or cholinergic drugs, monoamine oxidase inhibitors, antibiotics, diuretics, antiarrhythmic drugs and local anesthetics, anticonvulsants and psychotropic drugs; Other 12. participated in another drug (defined as receipt of a trial drug or placebo) or device clinical trial within 3 months before screening; 13. other circumstances that the investigator judged the participant to be ineligible for participation in the trial.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
The full official record for this study. This one lists no contact details, but it is the first place any would appear.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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The Third Xiangya Hospital of Central South University, Changsha, hunan
Changsha, Hunan, 410013, China